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N-of-1 Trials: FDA Plots Path to Regulation | RAPS

“At the very least, during the time needed to discover and develop an intervention, quantifiable, objective measures of the patient’s disease status should be identified and tracked, since, in an N-of-one experiment, evaluation of disease trends before and after treatment will usually be the primary method of assessing effectiveness,” Woodcock and Marks explained.

#n-of-1 #FDA #metrics - raps.org

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